BIODEL (BIOD) - unendeckter Biotech-Titel a.d. Diabetes-Forschung m. PHASE III Medikament - 500 Beiträge pro Seite

[yxcv1234]

Dieser Wert scheint noch niemanden im Board aufgefallen zu sein.
Will deshalb mal einen Thread aufmachen, da hier vielleicht "etwas gehen" könnte.
Bei regem Handel in New York ca.10 % im Plus. In Frankfurt bei minimalen Umsatz 30% im Plus. Der Langfristchart zeigt, wo der Wert mal war. Bleibt die Frage, ob´s in diese Richtung irgendwann in näherer Zukunft wieder gehen kann oder nicht.

[BrauchGeld]

Doch Biodel ist bekannt aber keiner will die Aktie , hier kannst du lesen warum ....

http://www.reuters.com/article/idUKL803245020080909

Biodel shares dive as diabetes study disappoints

LONDON (Reuters) - Shares of Biodel Inc (BIOD.O) plunged nearly 70 percent on Monday after a late-stage clinical trial cast doubt on its experimental diabetes drug VIAject.

[yxcv1234]

Antwort auf Beitrag Nr.: 38.929.782 von BrauchGeld am 11.02.10 21:12:24

Danke für die Antwort. Der Artikel ist 1,5 Jahre alt, d.h. der Grund für den Kurseinbruch. Könnte es sein, daß sie daß Problem fixen konnten ??

Wie es scheint, soll es Morgen in Basel eine Konferenz geben:

Biodel to Present Results from VIAject(R) Phase 3 Studies at Advanced Technologies and Treatments for Diabetes Conference in Basel

DANBURY, Conn., Feb 11, 2010 (BUSINESS WIRE) -- Biodel, Inc. /quotes/comstock/15*!biod/quotes/nls/biod (BIOD 3.93, +0.48, +13.97%) announced today that its chief executive officer, Dr. Sol Steiner, will present results from the company's two Phase 3 studies with VIAject(R) ultra-rapid-acting recombinant human insulin in a platform presentation at the 3rd International Conference on Advanced Technologies and Treatments for Diabetes in Basel, Switzerland, on Friday, February 12, 2010, at 1pm central European time. The presentation, entitled "Clinical Findings for Patients Treated with VIAject(R), An Ultra-Rapid Acting Formulation of Recombinant Human Insulin," will review and update key data from the VIAject(R) clinical development program. Dr. Steiner's presentation will be available on the company's website, www.Biodel.com, after the presentation.

[yxcv1234]

Schlusskurs in NY 3,89 (+ 13 %). Bin gespannt, ob Morgen Nachmittag/Abend schon etwas von der Konf. bekannt wird.

Hab mir mal die letzten Quartals-Zahlen angesehen, siehe: http://www.marketwatch.com/story/biodel-reports-first-quarte….

Laut Zahlen haben sie noch ca. 50 Mio.$ Cash und Assets, bei einer Markt.kap. von 92 Mio.$. Meines Erachtens gibt es somit noch genügend Luft nach oben für weiter steigende Kurse.

[yxcv1234]

Antwort auf Beitrag Nr.: 38.930.565 von yxcv1234 am 11.02.10 22:55:00

Hm, läuft heute nicht recht. Hoffentlich halten 3,5 $. Die News der heutigen Konferenz sind entweder noch nicht publik oder eher schlecht aufgenommen worden. Bin gespannt, wenn´s eine Veröffentlichung gibt.

[yxcv1234]

Kurs scheint sich bei 3,60 $ zu stabilisieren. News habe ich noch keine gefunden, aber laut Biodel Website werden wohl die Daten dort in Kürze (vielleicht Dienstag, da Montag Feiertag ??) bekanntgegeben.

February 11, 2010
Biodel to Present Results from VIAject(R) Phase 3 Studies at Advanced Technologies and Treatments for Diabetes Conference in Basel

... Dr. Steiner's presentation will be available on the company's website, www.Biodel.com, after the presentation. ...

http://investor.biodel.com/releases.cfm

[BrauchGeld]

Antwort auf Beitrag Nr.: 38.936.986 von yxcv1234 am 12.02.10 19:06:04

Kauf dir lieber etwas was nicht so riskant ist aber trotzdem viel glück damit .

Ist doch schon da ...
http://investor.biodel.com/events.cfm

[yxcv1234]

Antwort auf Beitrag Nr.: 38.937.025 von BrauchGeld am 12.02.10 19:10:06

Danke für den Rat, bin aber schon drin und warte erstmal ab, wie die Nachricht in den nächsten Tagen "nachwirkt". Diese Präsi hatte ich gesucht, Merci !

Bin zwar kein Fachmann, aber würde die Daten erstmal positiv interpretieren, insbesondere auf der Seite 6, wie schnell VIAject im Vergleich zu Konkurrenzprodukten mit der Wirkung beginnt, ereits nach 8-13 Minuten nach Einnahme.

... Allerdings steht bedauerlicherweise nichts drin, wann sie mit Phase 3 fertig sind und bis wann sie mit der Einführung rechnen. Das hätte meines Erachtens mit reingehört.

... und wie gesagt, charttechnisch gesehen bleibe ich bis 3,50 $ drin. Kann ja kaum tiefer gehen, aufgrund des hohen Cashbestandes, der noch bis nächstes Jahr reichen dürfte.

[BrauchGeld]

Die haben doch schon in Dezember 09 die Zulassung bei der FDA beantragt .

Biodel Submits VIAject® New Drug Application to FDA for Treatment of Diabetes

http://finance.yahoo.com/news/Biodel-Submits-VIAject-New-bw-…

[yxcv1234]

Antwort auf Beitrag Nr.: 38.937.352 von BrauchGeld am 12.02.10 19:50:25

Ja,bin schon zu lange am PC habs glatt überlesen.

Wurde zum Glück doch mit angesprochen !
Hab mal die Seite herauskopiert:

wso_0_652501fb66833e9ff0bb07d82babe678

[yxcv1234]

Antwort auf Beitrag Nr.: 38.937.422 von yxcv1234 am 12.02.10 19:59:58

Sorry, kleiner Fehler im Link:

[yxcv1234]

Ja, heute ist nichts passiert, aufgrund des Feiertags.

Zum vervollsändgen des Threads, hier mal ein Artikel vom 31.12.2010.

-----------------------------------------------------------------------------
http://www.minyanville.com/businessmarkets/articles/biodel-b…

Will Biodel Be the Comeback Company of 2010?
By Lisa LaMotta Dec 31, 2009 1:15 pm

Biodel (BIOD) could be the little biotech that could in 2010.

The Danbury, Conn.-based biopharmaceutical company filed a new drug application with the US Food and Drug Administration on Wednesday for its fast-acting injectible insulin VIAject to send its shares soaring 16% in early-morning trading on the last day of 2009 to linger around $4.70 per share.

“We believe our studies demonstrate that patients receiving VIAject had faster reductions in blood glucose activity, reduced risks of hyperglycemia and hypoglycemia and less weight gain than patients who received recombinant human insulin, and that VIAject may offer important clinical benefits to people with diabetes,” said Biodel Chairman Sol Steiner.

Despite the cheery ending to 2009, Biodel has seen its share of woes over the past few years. The company had a massive setback in September 2008 when data from late-stage trials of VIAject showed that the fast-acting insulin caused severe pain at the injection site when given in the 25 IU/ml dosage. The pain was so severe that 24 patients dropped out of the two studies. The stock fell from about $18.00 per share at the time to its current levels and has been widely ignored by investors ever since.

But Biodel could be the comeback kid of 2010. The company managed to adjust its dosage to 100 IU/ml and create a more promising product that,"And if approved by the FDA, could be a potential blockbuster. After spending over a year away from investor focus, 2010 may augur a turning point for BIOD. The company is still trying to shake off the aura of company with a failed Phase III drug and we believe the NDA filing this year will go a long way towards that goal,” wrote Leerink Swann analyst Josh Schimmer in a recent note to investors.

The drug caters to both type-1 and type-2 diabetics. Diabetes is a disease that affects 285 million, or 7%, of the adult population in the world, according to the International Diabetes Federation. The disease commonly comes in two types -- type 1 is an autoimmune disease that cannot be prevented and typically begins early in life, whereas type 2 diabetes is a preventable condition that tends to affect older, overweight patients. It's a leading cause of blindness, amputation, kidney failure, and stroke. VIAject is a fast-acting insulin that has proven to be more rapidly absorbed into the bloodstream than current standards of care. Its pen injection device makes it easy for patients to administer on their own.

(See, For Big Pharma, Diabetes Means Big Business.)

The upcoming year will be full of catalysts that should push the stock back up. The next milestone investors will be watching out for is the acceptance of the new drug application filing by the FDA, which typically occurs within 60 days of submission. This sets the date at which the FDA will decide about approval of the drug in the fourth quarter of 2010.

The only potential hindrance to the FDA’s acceptance of the new drug application for VIAject could be a small number of patients in a late-stage study from India. The number of patients in the study was reduced by one-third when Biodel had to exclude certain data after some of the samples were mishandled. While the FDA typically allows exclusion of data for this reason, the small sample size could be a bleak spot for the filing.

A lot hinges on the success of this drug for Biodel. The company has said that it cannot afford to bring VIAject to market by itself and will be looking for a partner from Big Pharma in the coming year. Leerink Swann’s Schimmer thinks that Sanofi-Aventis (SNY) will be an ideal partner for the little biotech. “Sanofi has the best selling long-acting insulin, Lantus, but its fast-acting insulin, Apidra, has fared poorly in the marketplace. By substituting VIAject for Apidra, Sanofi can offer a more compelling combination of ultra-fast and long acting insulins,” wrote Schimmer.

[yxcv1234]

Endlich zieht der Kurs wieder an! Aktuell bei 4.10 $ oder + 11% und steigenden Umsätzen. Bin eben mal wieder rein, da es charttechnisch spannend aussieht und der Weg bis 5 $ frei ist.



http://finance.yahoo.com/q/ta?s=biod&t=3m&l=on&z=l&q=c&p=v&a…

[yxcv1234]

Antwort auf Beitrag Nr.: 38.997.986 von yxcv1234 am 23.02.10 21:50:19

Ich schätze jetzt geht der Rebound los !

Before the Bell

BIOD
$ 4.68

Change
+0.69 +17.29%

[yxcv1234]

Antwort auf Beitrag Nr.: 39.032.796 von yxcv1234 am 01.03.10 14:16:36

Auch gibt es mal wieder eine positive News dazu !

DANBURY, Conn. - (Business Wire) Biodel Inc. (Nasdaq: BIOD) announced today that the U.S. Food and Drug Administration has accepted for review the company’s new drug application (NDA) seeking approval to market VIAject® for the treatment of diabetes. VIAject® is Biodel's proprietary formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs. It has been tested in more than 875 patients who participated in Phase 1, 2 and 3 clinical trials of the drug in the United States, Germany and India. Biodel submitted its marketing application to the FDA on December 30, 2009 and expects the Prescription Drug User Fee Act (PDUFA) action date for this NDA to be October 30, 2010

Read more: http://www.earthtimes.org/articles/show/fda-accepts-viajectr…

[yxcv1234]

Antwort auf Beitrag Nr.: 39.032.839 von yxcv1234 am 01.03.10 14:22:02

Wer sagt´s denn: renommierte Yale Universität ist drittgrößter institutioneller Anleger in BIOD, mit mehr als $4 Millionen !

----------------------------------
In report, a peek at Yale’s stocks

Could the secret to Yale Chief Investment Officer David Swensen’s legendary success be Hush Puppies shoes?

Probably not. The Yale Investments Office’s most recent quarterly report, filed with the U.S. Securities and Exchange Commission this month, provides a rare peek into the University’s closely guarded investment holdings — but only a peek. The report, which the University is legally required to file four times a year, shows Yale’s stake in companies ranging from a pharmaceuticals manufacturer to the maker of Hush Puppies. Still, given that most of Yale’s assets are not held under its own name but under other managers, the filing offers no window into the bulk of Yale’s $16.3 billion endowment.
“The report is not terribly indicative of anything,” said William Jarvis ’77, managing director of Commonfund Institute, a nonprofit consulting firm.

Like all institutional investors who control assets of at least $100 million, Swensen must disclose certain types of stocks and securities owned directly by Yale each quarter. According to the latest filing, Yale holds nearly $4 million, more than any other individual company listed, in shares of Biodel Inc., a company that recently developed a new method for injecting diabetes drugs. In fact, according to the company’s Yahoo! Finance profile, Yale is Biodel’s third largest institutional investor.

Biodel recently filed a drug application with the Food and Drug Administration to begin selling its technology, Biodel spokesman Seth Lewis said, adding that if its application is approved, the company’s share price will likely shoot up.
Still, $4 million is just “a drop in the bucket” compared to the rest of Yale’s endowment, said Richard Anderson, an endowment consultant at Hammond Associates.

The other securities Yale owns of individual companies, such as natural gas corporation Crosstex Energy and real estate developer Griffin Land and Nurseries, were donations to Yale that Swensen may be looking to sell, Anderson said. Yale also owns $829,000 of OpenTable, an online restaurant reservation provider that went public in May 2009.

And Yale also has $561,000 of Wolverine World Wide, a shoe manufacturer whose brands include not only Hush Puppies but also Patagonia, Hytest and Harley-Davidson footwear. In addition to its shoe brands, Wolverine World Wide operates a tannery that cures and sells raw pigskin and treats pigskin leather for shoes and other leather goods.

Though these holdings may not be representative of Yale’s endowment, the value of Yale’s stock holdings may reflect a recovery in some financial markets. The total value of securities Yale holds in its own name rebounded last quarter from its lowest point in at least eight years, rising from $5.2 million to $33.4 million. The rebound follows a huge drop-off from 2008 to 2009.

“For most of 2009, there was literally no activity,” Jarvis said. “These markets have now come back in a more subdued way. The market has come back somewhat, but no one would say that it’s robust.”

In the last quarter of 2009, the University owned 10 securities totaling $33.4 million, with the vast majority — 80 percent — of that money invested in three funds that rise and fall with the Standard & Poor 500 index, a group of the 500 largest companies, as well as with some international markets.

The largest overall stock holding reported in the filing was $23 million invested in SPDR Trust, an investment trust that owns shares of all 500 companies in the S&P 500. By mimicking the performance of the stock market, index funds and investment trusts such as SPDR allow institutional investors to make sure their stock portfolios perform as well as the stock market instead of forcing investors to put money in potentially risky individual companies, said Charles Ellis ’59, an investments consultant and a former member of the Yale Corporation Investments Committee.

If Yale wants to fix the proportion of its assets invested in the stock market, selling or buying index funds offers an easy and safe way to make sure the University’s portfolio does not drop too low or climb too high, Anderson said.

In the third quarter of 2009, Yale owned just $3.6 million of index funds in its own name, compared to just under $27 million in the quarter covered by the report. That may be because Yale’s allocation targets were disturbed during the economic meltdown last year, prompting Yale to stockpile index funds to rebalance, Jarvis said.

The SEC does not require the Investments Office to divulge any of its mutual funds or any so-called “alternative assets,” such as venture capital, private equity and real estate. And the billions in assets Yale owns indirectly through its investment managers do not appear in the report either.

“This is just an SEC requirement,” said David DeRosa, an adjunct professor of finance at the School of Management and the founder of an investment consulting firm. “Obviously, there’s a lot of stuff not in the report.”

Swensen did not respond to a request for comment. Neither did Kenneth Miller, Yale’s associate general counsel who filed the report.

[yxcv1234]

Antwort auf Beitrag Nr.: 39.044.926 von yxcv1234 am 02.03.10 20:57:19

Scheint so, als ob langsam auch wieder Empfehlungen für BIOD herausgegeben werden. Vermutlich nicht zu unrecht, da Monate oder Wochen vor einem potentiellen Zulassungs- bzw. Entscheidungstermin der FDA die Kurse sowieso fast automatisch nach oben gehen, siehe aktuell SOMX (Somaxon).

http://www.cnanalyst.com/2010/03/top-10-pharmaceutical-stock…

Top 10 Pharmaceutical Stocks with Highest Upside: HEPH, PRAN, CBRX, MIPI, XOMA, TTHI, BIOD, CXM, TRBN, MRNA (Mar 01, 2010)

... Biodel Inc (NASDAQ:BIOD) has the 7th highest upside potential in this segment of the market. Its upside is 269.7%. Its consensus target price is $14.75 based on the average of all estimates. ...

[Biobrandschutz]

Zitat von yxcv1234: Ich schätze jetzt geht der Rebound los !
Before the Bell
BIOD
$ 4.68
Change
+0.69 +17.29%

... naja, das war deutlich zu früh. In der vergangenen Woche haben sich auch noch einige Indexfonds für Smallcaps von der Aktie getrennt, weil BIODEL künftig nicht mehr in Russell3000 notieren wird. Soviel zu den negativen Nachrichten.

Es gibt viele Forscher, die von den von BIODEL entwickelten und patentierten Wirkstoffen vollends überzeugt sind. Fraglich ist unter den Fachleuten nur, ob BIODEL unterwegs nicht das Geld ausgehen könnte. Aufmerken lässt insofern eine wenig beachtete Mitteilung vom 13.05.2011, dass sich Great Point Partners LLC and Orbimed Advisors LLC durch einen direkten Kauf von 12,2 Mio. Aktien von der Gesellschaft als Investoren strategisch beteiligt haben - sie waren immerhin bereit 2,16 USD je Aktie zu zahlen. Great Point Partners LLC ist in der Medizininvestmentbranche noch ein unbeschriebenes Blatt, aber Orbimed Advisors LLC hat regelmäßig ein sehr gutes Gespür für erfolgreiche Biotech-Investments bewiesen. Es ist sicher kein Fehler, sich in dieses Fahrwasser zu wagen. Als positiv empfinde ich dabei, dass kaum jemand von der Aktie spricht und offensichtlich niemand auf eine marktschreierische Komponente baut.

Meine Einschätzung:
---> kaufen!

[nazard]

Guten Abend,
das hier ist nicht gerade ein Papier für schwache Nerven. Gestern 15% runter, heute 17% rauf. Mal sehen, zu welchen Resultaten die folgende Studie zu Diabetes Mellitus I führt:
The primary objective of this study is to assess the speed of absorption and onset of action of BIOD-105 and BIOD-107 and compare them to Humalog®. Study Start Date: March 2011, Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure).
Gruß von nazard

[MACD]

Antwort auf Beitrag Nr.: 41.647.004 von Biobrandschutz am 14.06.11 22:43:57

Wie es aussieht bist du schon länger in der Biobranche als Investor bzw. Spekulant aktiv.

"sie waren immerhin bereit 2,16 USD je Aktie zu zahlen"

Darüberhinaus beinhaltete der Kauf auch Warrants mit einem Bezugspreis um die 2,50 und einer Laufzeit von einigen Jahren.

Orbimed Advisors verwaltet mehrere Fonds, allerdings konnte ich keinen Performancenachweis finden. Ich werde mit das Portfolio nochmals genauer anschauen.

"hat regelmäßig ein sehr gutes Gespür für erfolgreiche Biotech-Investments bewiesen. "

Resultiert diese Aussage aus der längerfristigen Beobachtung der Einzelinvestments von Orbimed?

Zumindest optisch günstig sind derzeit auch Mannkind und Orexigen aufgrund abgelehnter FDA-Zulassungen.

Grüße

MACD

[Bioperle]

Das sind Wahnsinnsumsätze,

Real Time Stock Quotes: Biodel Inc. (BIOD)

6/24/2011 Market Closed
BIOD's NASDAQ Last Sale
1.81 0.14 8.38%
NLS Volume
5,146,978 Previous Close
$ 1.67
Today's High
$ 1.8200 Today's Low
$ 1.6500
52 Wk High
$ 6.08 52 Wk Low
$ 1.4895
NASDAQ Official Price
Open Price/Date
$ 1.68
Jun 24, 2011 Close Price/Date
$ 1.67
Jun 23, 2011


http://www.nasdaq.com/aspx/nlstrades.aspx?symbol=BIOD&select…

Mal abwarten was da noch kommt.

[Bioperle]

http://www.google.de/search?q=Biodel&rls=com.microsoft:de:IE…

[Bioperle]

Biodel Reports New Findings From Key Programs At Diabetes Technology MeetingPosted by admin on November 23,

2011Uncategorized five (1 votes)Healthcare Prof:Scientists from Biodel Inc. (Nasdaq: BIOD) reported new findings from the company’s Linjeta?, insulin glargine, “smart” basal insulin and stabilized glucagon development programs in poster presentations yesterday and in the Tenth Annual Diabetes Technologies Meeting in Bethesda, MD.Dr. Frank Flacke presented results of a Phase 1 single-center, double-blind, randomized crossover trial in 13 subjects with sort 1 diabetes who received a once-daily injection of Linjeta? or one of two modified formulations of Linjeta?, each on a separate day (“Characterization of Pharmacokinetics and Toleration of Three Variant Formulations of Linjeta?”). The purpose of the study was to compare the pharmacokinetic characteristics and toleration of Linjeta? towards the two modified formulations. The study located that the modified formulations were associated with improved toleration profiles and lower maximal insulin concentrations compared to Linjeta. Modified formulation BIOD-102 was related to a similar rate of absorption as Linjeta.Dr. Roderike Pohl reported results of in vitro and preclinical testing of a modified form of insulin glargine in diabetic miniature swine to assess its duration of activity and pharmacokinetic profile compared to insulin glargine (“A New Formulation of Insulin Glargine with an Extended Release Profile”). The study identified that certain excipients, when combined with insulin glargine, reduced the drug’s solubility and could prolong its duration of action to greater than 24 hours compared to an average 18.5 hours for insulin glargine.Nandini Kashyap described results of in vitro and in vivo studies in diabetic swine which showed that a “smart” basal insulin formulation can release insulin in response to changing glucose concentrations (“Smart Basal Insulin Formulation That Releases Insulin in Response to Altering Blood Glucose Concentrations”).